| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Major Depressive Disorders |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 6.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10057840 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| to evaluate the efficacy and safety and tolerability of two fixed dosages of Lu AA21004 5 and 10mg/day versus placebo after 6 weeks of treatment in patients with Major Depressive Disorder MDD . |
|
| E.2.2 | Secondary objectives of the trial |
| to evaluate the efficacy of Lu AA21004 5 and 10mg/day compared to placebo after 1 week of treatment - to evaluate the safety and tolerability of Lu AA21004 5 and 10mg/day compared to placebo during the course of the study - to evaluate the efficacy of Lu AA21004 5 and 10mg/day compared to placebo during the 6-week, doubleblind treatment period - to evaluate the proportion of patients who respond to Lu AA21004 treatment at Week 6 compared to placebo - to evaluate the proportion of patients who are in sustained response after 1 week of treatment with Lu AA21004 compared to placebo; to evaluate the proportion of patients who are in remission after 6 weeks of treatment with Lu AA21004 as compared to placebo |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
| 1. The patient is able to read and understand the Subject Information Sheet. 2. The patient has signed the Informed Consent Form. No study-related procedures may be performed before the patient has signed the form. 3. The patient suffers from a major depressive episode MDE as primary diagnosis according to DSM-IV-TR criteria classification code 296.xx . 4. The reported duration of the current Major Depressive Episode is at least 3 months and less than 12 months at screening. 5. The patient has a MADRS total score 30. 6. The patient is an outpatient, man or woman, aged between 18 and 65 years extremes included . 7. The patient, if female, must -agree not to try to become pregnant during the study, AND -use adequate contraception adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide , OR -have had her last natural menstruation at least 24 months prior to screening, OR -have been surgically sterilised prior to screening, OR -have had a hysterectomy prior to screening, OR -not be sexually active |
|
| E.4 | Principal exclusion criteria |
| 1. The patient has one or more of the following conditions -Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR assessed with the MINI - Current or past history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR. -Any substance disorder except nicotine and caffeine within the previous 6 months as defined in the DSM-IV-TR. - Presence or history of a clinically significant neurological disorder including epilepsy . - Neurodegenerative disorder Alzheimer s disease, Parkinson s disease, multiple sclerosis, Huntington s disease, etc. -Any axis II disorder that might compromise the study. 2. The patient has a significant risk of suicide according to investigator s opinion or presents a score 5 on item 10 suicidal thoughts of the MADRS. 3. The patient has a history of lack of response to previous treatment with venlafaxine. 4. The current depressive symptoms of the patient are considered by the investigator to have been resistant to two adequate antidepressant treatments of at least 6 weeks duration. 5. The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to venlafaxine. 6. The patient has used/uses disallowed recent or concomitant medication specified in Appendix II, Recent and Concomitant Medication , or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study. 7. The patient has received electroconvulsive therapy within 6 months prior to screening. 8. The patient is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study. 9. The patient has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, skin and subcutaneous tissue disorders or metabolic disturbance. 10. The patient suffers from and/or is under treatment for hypertension 11. The patient has clinically significant abnormal vital signs. 12. The patient has one or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant. 13. The patient has a clinically significant abnormal ECG. 14. The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability or efficacy. 15. The patient has been treated with any investigational medicinal product within 30 days 5 half lives whichever is longer prior to screening. 16. The patient is pregnant or breast-feeding. 17. The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason. 18. The patient is a member of the site personnel or their immediate families. 19. The patient is under forced treatment. 20. The patient has previously participated in this study. 21. The patient has previously been exposed to Lu AA21004. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Main endpoints of interest are MADRS total score at week 6, MADRS total score at week 1, and response rates at week 1. Also, MADRS total scores, HAM-D-24, HAM-A, CGI-S, CGI-I, SCL-90-R, SF-36, EuroQol and MADRS IVR version will be analysed at all time points. In addition safety is also an endpoint as measured by vital signs, ECGs, laboratory measurements, weight, physical examination, adverse events and withdrawal rates |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | Yes |
| E.6.13 | Others | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| farmaco attivo di riferimento |
|
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
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